Impact of Nicotine From Five Variants of a Nicotine Tablet on Attention in Adult Users of Nicotine Pouches: An Exploratory, Randomized, Controlled, Double-blind, Crossover Study

Philip Morris Products S.A.1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2025年10月28日最近更新: 2026年2月18日

干预措施NICOTINE TABLET-0.5mg NICOTINE TABLET-1.0mg NICOTINE TABLET-0mg NICOTINE TABLET-1.5mg NICOTINE TABLET-2.0mg

概览

阶段: 不适用
状态: 进行中（未招募）
发起方: Philip Morris Products S.A.
入组人数: 40
试验地点: 1
主要终点: Change in attentional performance after 15 minutes

概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

概览

简要总结

This study aims to provide initial insights into the impact of orally delivered nicotine on attentional performance in adult occasional users of nicotine pouches. Nicotine will be administered via a dissolvable tablet for approximately 10 minutes. The main objective of this exploratory study is to characterize the effect of nicotine on attentional performance, using metrics derived from Continuous Performance Test (CPT).

Additionally, a second CPT assessment will be conducted two hours after the first administration to explore the potential sustained effects of nicotine on attention as an exploratory objective.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Other
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

All subjects, the Sponsor, and CRO personnel will remain blinded to the product allocation (i.e., the nicotine content of the NICOTINE TABLET), the randomized sequence, and the live randomization scheme. This blinding will be maintained until the Statistical Analysis Plan (SAP) is finalized or the database is locked, whichever occurs later.

入排标准

年龄范围: 19 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Subject is able to understand the information provided in the ICF and has signed the ICF.
•Subject is a current non-daily user of nicotine pouches (past 30-day use) based on self-reported tobacco/nicotine-containing product use history.
•Subject expresses no desire to quit consumer nicotine product use within the next 3 months from Screening visit.

排除标准

•Subject uses or intents to start using nicotine replacement therapy or any other medication for smoking cessation.
•Subject uses other consumer nicotine products besides nicotine pouches more frequently than once per 30 days.
•Subject with a urine cotinine test exceeding 500 ng/mL.
•Subject has exhaled CO reading ≥ 10 ppm.
•Subject has reasons other than medical (e.g., psychological, social reason) to not participate in the study, as determined by the Investigator.
•Subject has a clinically relevant disease which requires medication or any other medical condition including clinically significant safety laboratory parameters at Screening visit, as determined by the Investigator.
•Subject has a positive serology test for HIV 1/2, hepatitis B or C.
•Subject has a positive urine drug test.
•Subject has a positive urine alcohol test.
•Subject has a visual or motor impairment that would interfere with their ability to perform a computer-based attentional task.